Demographic data and outcomes in patients with and without a history of digital ulcers (DUs) at inclusion (n=3196)
| Demographic data | HDU+ (n=1092) | HDU− (n=2104) | All patients (n=3196) | p Value* |
|---|---|---|---|---|
| Female sex | 83.8% | 88.3% | 86.8% | 0.002 |
| Age (years), mean±SD | 52.5±14.0 | 55.6±13.2 | 54.6±13.6 | <0.001 |
| Disease duration (years) | ||||
| Since first non-Raynaud symptom, mean±SD | 8.8±8.0 | 7.7±7.4 | 8.1±7.7 | <0.001 |
| Since onset of Raynaud's, mean±SD | 12.4±11.0 | 12.2±11.3 | 12.3±11.2 | 0.564 |
| Diffuse cutaneous subset | 41.7% | 29.1% | 33.4% | <0.001 |
| Anti-centromere positive | 28.0% | 38.0% | 34.6% | <0.001 |
| Anti-topoisomerase I positive | 42.4% | 28.9% | 33.5% | <0.001 |
| Raynaud's phenomenon present | 98.2% | 95.7% | 96.5% | <0.001 |
| Outcomes | ||||
| DUs reported since last visit | 77.2% | 34.1% | 48.3% | <0.001 |
| Active DUs at prospective visits | 34.6% | 14.0% | 20.6% | <0.001 |
| Skin involvement worsening | 40.1% | 41.5% | 41.0% | 0.508 |
| FVC <50% predicted | 5.4% | 3.0% | 3.8% | 0.004 |
| DLCO<40% predicted | 20.1% | 15.4% | 17.0% | 0.001 |
| LVEF<50% | 5.5% | 3.6% | 4.2% | 0.073 |
| Elevated US-PAPs | 39.7% | 34.5% | 36.2% | 0.004 |
| Scleroderma renal crisis | 1.7% | 1.6% | 1.6% | 0.887 |
| Death | 19.7% | 11.4% | 14.1% | <0.001 |
See the Methods section for definition of outcomes.
HDU+/HDU−, patients positive/negative for a history of DUs at baseline.
FVC <50% predicted, lung forced vital capacity <50% of the predicted value; DLCO<40% predicted, lung CO diffusion <40% of the predicted value; Elevated US-PAPs, a systolic pulmonary arterial pressure >40 mm Hg as measured by power Doppler heart ultrasound examination. For all these parameters values are considered at any visit including baseline.
*Significance of the difference between HDU+ and HDU− patients, by χ2 test (for categorical variables) or independent samples t test (for numeric variables).